An Investigator-initiated Trial to Evaluate the Efficacy and Safety of Anti-CD19 Universal CAR-T Cells in the Treatment of Relapsed/Refractory(r/r) CD19+ B-cell Acute Lymphoblastic Leukemia(B-ALL)
This is a single-arm, single-center, open-labeled clinical study to evaluate the safety and efficacy of UCAR-T Cells injection for patients with relapsed/refractory(r/r) B-cell Acute Lymphoblastic Leukemia(B-ALL).
• Male or female, aged 2-75 years;
• A definite diagnosis of relapsed/refractory B-ALL and a percentage of primitive/naive lymphocytes \>5% in bone marrow at baseline (flow cytometry);
• CD19 expression was positive in bone marrow or peripheral blood tumor cells;
• ECOG score 0-2 points;
• Expected survival time ≥3 months;
• Adequate liver, kidney, heart and lung function;
• Patients who have recovered from acute toxic effects of prior chemotherapy should be excluded from the trial at least one week apart;
• Women of childbearing age have negative blood pregnancy test before the start of the trial, and agree to take effective contraceptive measures during the trial until the last follow-up; male subjects with partners of childbearing potential agree to take effective contraceptive measures during the trial until the last follow-up;
• Voluntarily sign the informed consent.